In particular, the Italian agency said its main concerns were that drugs that failed to meet established quality control criteria are not rejected.
Employees at Sri Krishna “routinely use the PC administrator privileges to set the controlling time and date settings back to over-write previously collected failing and/or undesirable sample results. This practice is performed until passing and/or desirable results are achieved.”
In addition, inspectors found that company employees routinely performed “trial” injections of sample aliquots prior to performing the official analysis. The results of these trials are not reported, and were found to “differ significantly from the subsequent reported results… The resulting raw data chromatogram files were often found to have been deleted and unavailable for review.”
The company’s electronic records also were seen as not meeting systems validation ensuring they are trustworthy, reliable and generally equivalent to paper records
Inspectors also found “torn and discarded controlled manufacturing batch records for a variety of different products issued by the Quality Unit.”
Meanwhile, five batch records were compared with the archived manufacturing one and it was ascertained that no records had been made for duplicate issuance of these five batches chosen for review.
Finally, the Italian regulators said that the current GMP certificates issued in March 2013 and November 2013 are invalid. “It is proposed to withdraw also the GMP Certificate issued by Baden – Württemberg (Germany) on 04 August 2014,” the Italian agency said.
However, the agency did not move to ban products from the company as “there is no reason of concern regarding the quality of the batches of finished products for the following reasons: - only intermediates granules to be further processed by other manufacturing plants of finished products are manufactured in the inspected units; - the finished product is further tested by the batch release site before the release on the market. If no full testing (including impurities) of the finished product has been performed before the release, National Competent Authorities should consider immediate recall of the already released batches and prohibition of supply of further batches using Sri Krishna sourced granules.
As an alternative National Competent Authorities may request Marketing Authorisation Holders to conduct a risk assessment in order to evaluate the risk to product quality and patients from the issues identified.
The GMP certificate withdrawal does not impact any of Sri Krishna's API manufacturing sites.